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BIO-DIVERSITY RULES 2024 AND PATENT
BIO-DIVERSITY RULES 2024 AND PATENT
In exercise of the powers conferred by Section 62 of the Biological Diversity Act, 2002 (18 of 2003) and in supersession of the Biological Diversity Rules, 2004, the Central Government at this moment amended the rule dated October 22, 2024. The rules will come into force effective from December 22, 2024 (From the expiry of 60 days from the date of notification in the Official Gazette).
A person who shall be required to take the approval of the National Biodiversity Authority, (a) a person who is not a citizen of India; (b) a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961; (c) a body corporate, association or organization- (i) not incorporated or registered in India; or (ii) incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management. (Sub section (2) of Section (3)).
If any person covered under sub-section (2) of section 3 of the Act, intends to use the results of research for obtaining intellectual property rights by the transferee shall apply for prior approval of the NBA under rule 15 of the Act.
If the requisite information sought by the authority has not been provided within thirty days from the date of seeking information, the application shall be closed.
If the NBA authority is satisfied with the merit of the application, it will decide on granting approval subject to terms and conditions, including benefit sharing, or reject it, as deemed fit, within ninety days of receiving it. However, the application shall not be rejected unless given a reasonable opportunity to be heard.
The approval is in the form of an agreement, if the applicant does not sign the agreement within sixty days from the date of communication of the draft agreement, an application shall be closed; however, the Applicant can revive such closed application on receipt of half of the fees with respect to the fresh application within ninety days.
Any person referred to in subsection (2) of section 3 of the Act, intends to apply for Intellectual property right, in or outside India for the invention based on research or information including any biological resource or digital sequence information (DSI) that is access from India, deposited in repositories outside India, or traditional knowledge associated thereto, shall seek prior approval of the NBA authority before granting of Intellectual property right in India or elsewhere under rule 16 (1) of the Act.
If the requisite information sought by the authority has not been provided by the applicant within ninety days; an application shall be closed; however, the Applicant can revive such closed application on receipt of half of the fees with respect to the fresh application within ninety days.
If the NBA authority is satisfied with the merit of the application, take a decision on approving in the form of the agreement subject to terms and conditions, including benefit sharing, or reject an application as deemed fit, within a period of one hundred and eighty days from the receipt of the application. However, the application shall not be rejected unless given a reasonable opportunity to be heard.
If the applicant does not sign the agreement within ninety days from the date of communication of the draft agreement, an application shall be closed; however, Applicant can revive such closed application on receipt of half of the fees with respect to fresh application within ninety days.
Applicant shall intimate the authority within forty five days from the grant of the Intellectual property right.
The person who is not covered under sub section (2) of section 3, and fall under the purview of i.e. No person, who is a citizen of India or a body corporate, association or organization which is registered in India, shall obtain any biological resource for commercial utilization, or bio-survey and bio-utilization for commercial utilization except after giving prior intimation to the State Biodiversity Board concerned: Provided that the provisions of this section shall not apply to the local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practicing indigenous medicine (Section 7) intends to apply for Intellectual property right, in or outside India for the invention based on research or information including, any biological resource or digital sequence information (DSI) that is access from India, deposited in repositories outside India, or traditional knowledge associated thereto, shall seek prior approval of the NBA authority before grant of Intellectual property right in India or elsewhere under rule 16 (2) of the Act.
If the authority is of opinion that such an invention is the result of access to the knowledge held by the community or an individual or a group of individual in an illegal manner, the authority may recommend to the adjudicating officer to impose a higher penalty with regards to damage.
The applicant has to provide an undertaking at the time of registration that prior approval of the authority will be taken before the commercialization of the Intellectual property right under rule 16 (2).
The applicant shall intimate the authority within forty-five days from the grant of the Intellectual property right.
Any person referred under section 7, intends to commercialize the Intellectual property rights shall obtain prior approval of the NBA authority under rule 16 (3) of the Act.
If the NBA authority is satisfied with the merit of the application, decide on approving in the form of an agreement subject to terms and conditions, including benefit sharing, within a period of one hundred and eighty days from the receipt of the application.
If the applicant does not sign the agreement within ninety days from the date of communication of the draft agreement, an application shall be closed; however, the Applicant can revive such closed application on receipt of half of the fees with respect to fresh application within ninety days.
If any Indian or foreign entity uses a biological resource from a foreign country for research or commercial purposes or to obtain the Intellectual property rights shall submit a declaration for sustainable use of plans, and programs for the conservation and sustainable use of biological diversity including, promotion of in situ, and ex-situ, conservation of biological resources including cultivars, folk varieties and landraces, incentives for research, training and public education to increase awareness concerning biodiversity. (Section 36A and rule 18 of the Act)
Any person referred under section 7, intends to claim an exemption for accessing cultivated medicinal plants shall submit a self-declaration that includes details i.e., the name and address of the applicant and the cultivator, geographical location including survey number, extent of area under cultivation along with the details of the species being cultivated, and parts thereof, and approximate quantity of the biological resources being accessed; in physical or digital form to obtain a certificate of origin for the cultivated medicinal plant from the Biodiversity Management Committee under rule 19.
The onus of proof of the source of origin of the medicinal plants shall lie on the end-user.
Author : Kinjal Shah
Designation: Patent Attorney
Date: November 29, 2024 |
